Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tub
FDA device recall Z-0035-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- VIASYS Med Systems
- Reason for recall
- The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Action taken
- VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/10-11/03, informing them of the potential for a blocked exhalation hole in the sideport relief valve cap which may result in excess pressure build-up. The accounts were instructed to check their inventory for the affected catalog numbers and lots numbers, place any found on hold for return to VIASYS, and sub-recall the affected product from their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAI
- Quantity affected
- 60 units
- Distribution
- Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.
- Date initiated
- 2003-09-10
- Date posted
- 2003-10-15
- Date terminated
- 2004-03-24
- Location
- Wheeling, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BABYSET AND PAC (PULMONARY ASSIST CIRCUIT) (K930252) | Bird Life Design | 1993-02-09 |